Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix

In addition, the expert panel suggested that Alkem Laboratories should submit published pharmacokinetic/pharmacodynamic (PK/PD) data and data on the ratio of serum to CSF concentration.

Furthermore, the committee stated that the firm should submit the minimum effective concentration in CSF required for the pharmacological action of the proposed drug.

This came after Alkem Laboratories presented the BE study report before the committee.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer.

Relugolix is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the BE study report presented by the Alkem Laboratories.

After detailed deliberation, the committee opined that the firm should submit the following before the committee for further consideration:

1. Justification/clarification regarding significant inter-subject variability in presented BE study data.

2. Published PK/PD data

3. Data on the ratio of serum to CSF concentration

4. Minimum effective concentration in CSF required for pharmacological action of the proposed drug.

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